Organoleptically acceptable indole serotonin receptor agonist oral dosage formulations and methods of using the same

Abstract

Organoleptically acceptable oral dosage formulations of an indole receptor serotonin agonist, and methods of making and using the same, are provided. An aspect of the formulations is that they include an indole receptor serotonin agonist and a masking component. In certain embodiments, the masking component includes one or more of an amino acid and an organic acid. The subject invention finds use in a variety of applications.

1 . An organoleptically acceptable oral dosage formulation of an indole serotonin receptor agonist, said formulation comprising:
 an indole serotonin receptor agonist; and   a masking component, wherein said masking component is an amino acid or an organic acid.   
   
   
       2 . The formulation according to  claim 1 , wherein said masking component is an amino acid. 
   
   
       3 . The formulation according to  claim 2 , wherein said amino acid is glutamic acid or glycine. 
   
   
       4 . The formulation according to  claim 1 , wherein said masking component includes an organic acid. 
   
   
       5 . The formulation according to  claim 4 , wherein said organic acid is chosen from citric acid, malic acid and ascorbic acid. 
   
   
       6 . The formulation of  claim 1 , wherein said indole serotonin receptor agonist is selected from sumatriptan, frovatriptan, zolmitriptan, eletriptan, rizatriptan, naratriptan, and almotriptan or a pharmaceutically acceptable salt thereof. 
   
   
       7 . The formulation according to  claim 1 , wherein said oral dosage formulation is an oral film, lozenge, tablet, gel or gum. 
   
   
       8 . A method of delivering a therapeutic amount of an indole serotonin receptor agonist to an individual in need thereof, the method comprising:
 administering to said individual an organoleptically acceptable oral dosage formulation of an indole serotonin receptor agonist, said formulation comprising:   an indole serotonin receptor agonist; and   a masking component, wherein said masking component is an amino acid or an organic acid.   
   
   
       9 . The method according to  claim 8 , wherein said administering comprises introducing said formulation sublingually to said individual. 
   
   
       10 . The method according to  claim 8 , wherein said masking component is an amino acid. 
   
   
       11 . The method according to  claim 10 , wherein said amino acid is glutamic acid or glycine. 
   
   
       12 . The method according to  claim 8 , wherein said masking component includes an organic acid. 
   
   
       13 . The method according to  claim 12 , wherein said organic acid is chosen from citric acid, malic acid and ascorbic acid. 
   
   
       14 . The method according to  claim 8 , wherein said indole serotonin receptor agonist is selected from sumatriptan, frovatriptan, zolmitriptan, eletriptan, rizatriptan, naratriptan, and almotriptan or a pharmaceutically acceptable salt thereof. 
   
   
       15 . The method according to  claim 8 , wherein said oral dosage formulation is an oral film, lozenge, tablet, gel or gum. 
   
   
       16 . The method according to  claim 8 , wherein said method is a method of treating a headache. 
   
   
       17 . The method according to  claim 8 , wherein said method is a method of preventing a headache. 
   
   
       18 . The method of  claim 8 , wherein the method provides for a level of indole serotonin receptor agonist in the individual that is effective to inhibit migraine pain. 
   
   
       19 . A kit comprising an organoleptically acceptable oral dosage formulation of an indole serotonin receptor agonist. 
   
   
       20 . The kit according to  claim 19 , wherein said oral dosage formulation is a lozenge, tablet, gel or gum.